
Our Services
At Mediscient Devices, we offer innovative medical injectors and a range of services that includes benchmarking, product design, process development, assembly machines, and production. Our team of experts is dedicated to providing you with a seamless experience and ensuring the success of your medical equipment manufacturing projects.
Benchmarking
Design
Prototyping
Process Design
Mold Development
Assembly Machine Development
Product Development
Production Line
Development
Technical Documentation
& Product Filing
Commercial
Supply
Product & Process Validations
Product Development
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User step analysis
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Force testing at each and every step
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21CFR compliant testing equipment
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With audit trail reporting
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Material Identification tests in associated labs
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FTIR
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DSC
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Residue
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Patent Study
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Inhouse study
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Patent attorney associate
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Mechanism study:
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Measuring every dimension of all component parts
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Measuring forces of every functional feature of all component parts
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Identifying part manufacturability details like parting lines, gate points, ejection points, etc.
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Hot tip cutters, surgical cutters, handheld motorized micro cutter for opening up the devices/ cutting sections
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Reverse Engineering with NABL calibrated equipment
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1micron LC camera Vision Measurement Machine (VMM)
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21 CFR Universal Testing Machine (UTM)
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Different Force gauges
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Vernier calipers, Micrometers, height gauge, surface plate, runout dial gauge and stylus, etc.
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Custom gauges
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3d model generation
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Part modeling
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Generating parting lines
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Creating gate points and ejection points
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Component assembly
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Rendering
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Production Line Development
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Define process requirements
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Assembly sequencing
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Define assembly requirements
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Define, Assembly Concept
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Define SPM/equipment for assembly
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Molding process design and development
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Validation protocols development (IQ, OQ, PQ)
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Define tool certification/validation requirements and ensuring all relevant data.
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Define Scientific Mold Validation Protocol
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Define product approval criteria, batch release criteria
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Define product testing protocols (3rd party lab)
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Listing Product certification requirements
Product Filing & Commercial Supply
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Design History File (DHF)
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User Needs (URS)​
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Design Input
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Design Output
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Design Verification
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Bench testing
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Design Validation
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DV & DVL testing
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Risk Management File
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Risk Management Plan (RMP)
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Hazard Assessment (IHA)​
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Different types of Failure Mode Analysis
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Benefit Risk
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Risk Summary
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US DMF filing
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Device History File